Exercise and Tumor Blood Flow in Breast Cancer Patients

Cancer, Breast Clinical Trial

— EXETUMOR2  

Official title:

Exercise and Tumor Blood Flow in Breast Cancer Patients (Exetumor 2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04416087
• Other study ID #: T148/2020
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2020
• Source: Turku University Hospital
• Contact: Ilkka Heinonen, PhD
• Phone: +35823138145
• Email: ilkka.heinonen[@]utu.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research aims at investigating tumor blood flow response to acute exercise in human cancer patients. It is hypothesized and expected that acute exercise increases tumor blood flow, which could plausibly increase the efficacy of cancer treatment.

Description:

Physical activity has been applied as an adjunctive therapy in the secondary prevention of many cancers, but very little is currently known clinically and mechanistically about the effects of physical activity and exercise on tumor itself. Based on recent evidence from pre-clinical studies, it is plausible to expect that changes in tumor blood flow and its heterogeneity, oxygenation, and metabolism due to exercise would increase the delivery of chemotherapy and other cancer drugs into the tumor increasing the efficacy of cancer treatment.

Twenty (20) newly diagnosed Breast cancer patients will be recruited to investigate whether these pre-clinical findings can be extended to humans to serve as an evidence-based proof-of-concept for the possible inclusion of exercise in the treatment of cancer during chemotherapy. To study the effect of acute physical exercise on tumor blood flow and its heterogeneity, supine bicycle exercise in a positron emission tomography (PET) scanner will be used to exercise Breast cancer patients. These experiments are additional measurements to their normal treatments, and no new interventional approaches will be conducted in this study.

The study consists of one fitness test assessment, and tumor blood flow measurements with PET at rest and during supine cycling exercise.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• newly diagnosed breast cancer

Exclusion Criteria:

• abnormal fatigue, anemia, or physical dysfunction due to the disease

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer, Breast

Intervention

Other:
• Exercise
Positron emission tomography (PET) imaging at rest and during supine bicycle exercise Tumor blood flow and its heterogeneity will be measured with PET at rest and during supine bicycle exercise.

Locations

Country	Name	City	State
Finland	Turku PET Centre	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor blood flow	Measured with PET and radiowater ([(15)O]H2O) tracer. Tumor perfusion will be determined as mean tumor blood flow.	Tumor blood flow is measured at one time point, at least two (2) days apart from baseline fitness test assessment. Tumor blood flow at rest and during supine cycling exercise will be measured on the same day.
Secondary	Spatial dispersion (heterogeneity) of tumor blood flow	Measured with PET and radiowater ([(15)O]H2O) tracer. Tumor blood flow heterogeneity will be determined as voxel variation in perfusion divided by the mean perfusion of the voxels.	The heterogeneity of tumor blood flow is measured at one time point, at least two (2) days apart from baseline fitness test assessment. The heterogeneity of tumor blood flow at rest and during supine cycling exercise will be measured on the same day.